Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard.

Computational modeling and simulation (CM&S) is a key tool in medical device design, development, and regulatory approval. For example, finite element analysis (FEA) is widely used to understand the mechanical integrity and durability of orthopaedic implants. The ASME V&V 40 standard and supporting FDA guidance provide a framework for establishing model credibility, enabling deeper reliance on CM&S throughout the total product lifecycle. Examples of how to apply the principles outlined in the ASME V&V 40 standard are important to facilitating greater adoption by the medical device community, but few published examples are available that demonstrate best practices. Therefore, this paper outlines an end-to-end (E2E) example of the ASME V&V 40 standard applied to an orthopaedic implant. The objective of this study was to illustrate how to establish the credibility of a computational model intended for use as part of regulatory evaluation. In particular, this study focused on whether a design change to a spinal pedicle screw construct (specifically, the addition of a cannulation to an existing non-cannulated pedicle screw) would compromise the rod-screw construct mechanical performance. This question of interest (?OI) was addressed by establishing model credibility requirements according to the ASME V&V 40 standard. Experimental testing to support model validation was performed using spinal rods and non-cannulated pedicle screw constructs made with medical grade titanium (Ti-6Al-4V ELI). FEA replicating the experimental tests was performed by three independent modelers and validated through comparisons of common mechanical properties such as stiffness and yield force. The validated model was then used to simulate F1717 compression-bending testing on the new cannulated pedicle screw design to answer the ?OI, without performing any additional experimental testing. This E2E example provides a realistic scenario for the application of the ASME V&V 40 standard to orthopedic medical device applications.

Corrosion resistance of a Nitinol ocular microstent: Implications on biocompatibility.

Nitinol is commonly used in medical implants due to its unique thermomechanical properties of shape memory and superelasticity. Free nickel has the potential to induce biological responses that may be a concern for permanent implants manufactured from nickel-containing alloys. Although there are extensive reports on the effects of surface treatments on corrosion behavior in cardiovascular Nitinol implants, there is a lack of data on corrosion resistance and impact on biocompatibility for ocular implants. Therefore, the objective of this study was to determine localized corrosion and nickel elution resistance of an electropolished Nitinol-based ocular device (Hydrus Microstent, Ivantis, Inc.) intended for patients with primary open angle glaucoma. Pitting corrosion susceptibility was characterized by potentiodynamic polarization testing per ASTM F2129. In addition, nickel ion release was quantified with immersion testing to 63 days. The results indicated high localized corrosion resistance as all samples reached polarization potentials of 800 mV without pitting initiation. Maximum nickel elution rates per device were less than approximately 1.1 ng/device/day after the first day of immersion and reduced to less than 0.1 ng/device/day after 7 days. For a patient with bilateral microstents, these nickel concentrations are ×10,000 lower than previously published tolerable intake levels for systemic toxicity. Overall, these corrosion results are in good agreement with literature values of well processed and biocompatible Nitinol devices indicating adverse systemic biological responses are not expected in vivo.

Differences in Trabecular Bone, Cortical Shell, and Endplate Microstructure Across the Lumbar Spine.

BACKGROUND: The quality of the vertebral body structures such as endplate, cortex, and trabecular bone is important for understanding the performance of implants, particularly at the bone-implant interface. Although vertebral body structures have been analyzed separately in the literature, there is no comprehensive study to assess these anatomical measurements along with their interrelationships in the lumbar spine. Therefore, the purpose of this study was to assess variations in trabecular microstructure, vertebral endplate thickness and concavity, and vertebral body cortex thickness within the lumbar spine. METHODS: A total of 80 lumbar vertebrae (L1-L5) were dissected from 16 human cadaver specimens and imaged with microcomputed tomography to determine trabecular microstructure, vertebral cortex thickness, endplate thickness, and maximum endplate concavity depth. A paired t test and regression analysis were used to determine significant differences (P < .05) between different vertebral levels and correlations between the analyzed anatomical parameters. RESULTS: L1 vertebra had significantly better (P < .02) trabecular bone microstructure (eg, trabecular bone volume fraction) than all other lumbar vertebrae. However, L1 vertebra also had significantly thinner (P ≤ .02) anterior, left, and right cortices compared to all other vertebral levels. Within L3-L5 intervertebral disc spaces, cranial endplates had significantly greater (P ≤ .03) thickness and maximum concavity depth compared to their respective caudal endplates. No strong correlations were observed between trabecular bone microstructure, maximum endplate concavity depth, vertebral cortex, and endplate thickness parameters. CONCLUSIONS: Detailed reference data of these anatomical parameters for each lumbar vertebral body can aid in improved understanding of bone quality, particularly when assessing different implant designs and fixation approaches. Moreover, such anatomical knowledge may help clinicians with optimal implant design selection and surgical placement of these devices into their respective locations.

Mechanical performance of traditional distraction-based dual growing rod constructs.

BACKGROUND: Growing rod constructs are an important contribution in the treatment of children with early onset scoliosis even though these devices experience high rates of rod fracture. The mechanical performance of traditional, distraction-based dual growing rod constructs is not well understood, and mechanical models for predicting device performance are limited. PURPOSE: Two mechanical models were developed and used to determine the mechanical performance of various growing rod configurations by increasing construct complexity. STUDY DESIGN/SETTING: Mechanical bench testing and finite element (FE) analysis. METHODS: Static and dynamic compression bending tests were based on an ASTM F1717 method modified to accommodate dual growing rod constructs. Six construct configurations were tested, mechanical properties were recorded, and statistical analyses were performed to determine significant differences between groups: (1) no connectors (rods only), (2) side-by-side connectors, (3) side-by-side connectors plus 4 crosslinks, (4) (40-mm long tandem connectors, (5) 80-mm long tandem connectors, and (6) 80-mm long tandem connectors plus 4 crosslinks. FE analysis was used to predict the stress distribution within the constructs. RESULTS: The static results indicated greater stiffness, yield load, and peak load as the axial connector length increased (side-by-side to 40 mm tandem to 80 mm tandem). The dynamic results showed similar cycles to failure for side-by-side and tandem connector (40 and 80 mm) construct configurations without crosslinks. Crosslinks shifted the location of rod fracture observed experimentally and significantly reduced the fatigue life of the construct. The flexibility of the construct decreased significantly as the axial connector length increased. FE predictions were highly consistent with the experimentally measured values and provided information on stress distribution within the rod for comparison to experimental fracture locations. CONCLUSIONS: This is the first study to evaluate mechanical performance of various configurations of pediatric growing rod constructs using preclinical models. The current study is consistent with a previous retrieval study in that rigid constructs lacking flexibility (ie, higher stiffness and lower displacement), such as those with 80-mm tandem connectors and multiple crosslinks, demonstrated decreased mechanical performance as shown through both experimental and computational models. Additionally, the experimental and computational findings suggest that surgeons should strategically consider the number of interconnecting components and subsequent stress concentrations along the posterior side of the rod. For example, changing the placement of crosslinks to low stress regions of the construct or not using crosslinks in the construct are options.

The Effects of Bone Microstructure on Subsidence Risk for ALIF, LLIF, PLIF, and TLIF Spine Cages.

Several approaches (anterior, posterior, lateral, and transforaminal) are used in lumbar fusion surgery. However, it is unclear whether one of these approaches has the greatest subsidence risk as published clinical rates of cage subsidence vary widely (7-70%). Specifically, there is limited data on how a patient's endplate morphometry and trabecular bone quality influences cage subsidence risk. Therefore, this study compared subsidence (stiffness, maximum force, and work) between anterior (ALIF), lateral (LLIF), posterior (PLIF), and transforaminal (TLIF) lumbar interbody fusion cage designs to understand the impact of endplate and trabecular bone quality on subsidence. Forty-eight lumbar vertebrae were imaged with micro-ct to assess trabecular microarchitecture. micro-ct images of each vertebra were then imported into image processing software to measure endplate thickness (ET) and maximum endplate concavity depth (ECD). Generic ALIF, LLIF, PLIF, and TLIF cages made of polyether ether ketone were implanted on the superior endplates of all vertebrae and subsidence testing was performed. The results indicated that TLIF cages had significantly lower (p < 0.01) subsidence stiffness and maximum subsidence force compared to ALIF and LLIF cages. For all cage groups, trabecular bone volume fraction was better correlated with maximum subsidence force compared to ET and concavity depth. These findings highlight the importance of cage design (e.g., surface area), placement on the endplate, and trabecular bone quality on subsidence. These results may help surgeons during cage selection for lumbar fusion procedures to mitigate adverse events such as cage subsidence.

Impact of nitinol stent surface processing on in-vivo nickel release and biological response.

Although nitinol is widely used in percutaneous cardiovascular interventions, a causal relationship between nickel released from implanted cardiovascular devices and adverse systemic or local biological responses has not been established. The objective of this study was to investigate the relationship between nitinol surface processing, in-vivo nickel release, and biocompatibility. Nitinol stents manufactured using select surface treatments were implanted into the iliac arteries of minipigs for 6 months. Clinical chemistry profile, complete blood count, serum and urine nickel analyses were performed periodically during the implantation period. After explant, stented arteries were either digested and analyzed for local nickel concentration or fixed and sectioned for histopathological analysis of stenosis and inflammation within the artery. The results indicated that markers for liver and kidney function were not different than baseline values throughout 180 days of implantation regardless of surface finish. In addition, white blood cell, red blood cell, and platelet counts were similar to baseline values for all surface finishes. Systemic nickel concentrations in serum and urine were not significantly different between processing groups and comparable to baseline values during 180 days of implantation. However, stents with non-optimized surface finishing had significantly greater nickel levels in the surrounding artery compared to polished stents. These stents had increased stenosis with potential for local inflammation compared to polished stents. These findings demonstrate that proper polishing of nitinol surfaces can reduce in-vivo nickel release locally, which may aid in minimizing adverse inflammatory reactions and restenosis. STATEMENT OF SIGNIFICANCE: Nitinol is a commonly used material in cardiovascular medical devices. However, relationships between nitinol surface finishing, in-vivo metal ion release, and adverse biological responses have yet to be established. We addressed this knowledge gap by implanting single and overlapped nitinol stents with different surface finishes to assess systemic impact on minipigs (i.e. serum and urine nickel levels, liver and kidney function, immune and blood count) over the 6 month implantation period. In addition, nickel levels and histopathology in stented arteries were analyzed on explant to determine relationships between surface processing and local adverse tissue reactions. The findings presented here highlight the importance of surface processing on in-vivo nickel release and subsequent impact on local biological response for nitinol implants.

Effects of tissue digestion solutions on surface properties of nitinol stents.

Analysis of explanted medical implants can provide a wealth of knowledge about device safety and performance. However, the quality of information may be compromised if the methods used to clean tissue from the device disturb the retrieved condition. Common solutions used to digest tissue may adversely affect the surface of the device and its severity can be material and processing dependent. In this study, two groups of stents made from the same material (Nitinol) were shape set in a salt pot (SP) or further processed by mechanical polishing (MP) and then immersed in one of three tissue digestion solutions (TDS): nitric acid (HNO3 ), sodium hydroxide (NaOH), or papain enzyme (papain). Nickel (Ni) ion concentrations were measured for each stent-TDS combination and post-immersion stent surface constituents, morphology and oxide depths were compared to baseline samples. Exposure to the HNO3 TDS resulted in relatively high Ni ion release and surface damage for both stent types. Papain TDS induced a greater Ni ion release than NaOH TDS, however, both were significantly lower than HNO3 . The NaOH TDS increased the oxide layer thickness on MP stents. In contrast, all other stent immersions resulted in thinner oxide layers. For the Nitinol finishes used in this study, HNO3 is not recommended while papain and NaOH solutions may be appropriate depending on the post-retrieval analysis performed. This study elucidates the importance of preliminary testing for TDS selection and how the surface finish can affect the sensitivity of a material to a TDS. 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 331-339, 2018.

Impact of bone quality on the performance of integrated fixation cage screws.

BACKGROUND CONTEXT: Commercially available lumbar integrated fixation cages (IFCs) have variable designs. For example, screw-based designs have up to four screws inserted at different locations across the vertebral end plate as well as at different angles in the sagittal and transverse planes. This is important as end plate and trabecular bone quality may vary across the vertebra and may affect the screw's fixation ability, particularly if bone purchase at the bone-screw interface is poor. PURPOSE: This study aimed to evaluate whether variations in local bone quality surrounding IFC screws inserted at different locations in the vertebrae would affect their mechanical performance. STUDY DESIGN: This study is an in vitro human cadaveric biomechanical analysis. MATERIALS AND METHODS: Fourteen lumbar (L3 and L4) vertebrae from 10 cadavers (age: 76±10 years, bone mineral density: 0.89±0.17 g/cm2) were used for this study. Pilot holes (3.5-mm diameter×15-mm length) representing three different IFC screw orientations (lateral to medial [LM], midsagittal [MS], and medial to lateral [ML]) were created in vertebrae using an IFC guide and bone awl. The screw locations and trajectories chosen are representative of commercially available IFC designs. These pilot holes were then imaged with high-resolution microcomputed tomography to obtain a three-dimensional structure of the bone surrounding the pilot hole. Local bone morphology was then quantified by evaluating a 3-mm-thick circumferential volume surrounding the pilot hole. Integrated fixation screws were implanted into pilot holes while recording maximum screw insertional torques. Screws were toggled in the cranial direction from 10 to 50 N for first 10,000 cycles, and the maximum load was increased by 25 N for every 5,000 cycles for a total of 25,000 cycles. RESULTS: Total bone volume (BV) and trabecular bone volume fraction surrounding ML screws were significantly greater (p<.03) compared with those around MS screws and LM screws. The maximum insertional torque for ML screws were greater (p=.06) than LM and significantly greater (p<.02) than MS screws. The number of cycles to failure for the ML screw was significantly greater (p<.04) than that for the LM and the MS screws. Total BV (R2≤46.2%, p<.03) and the maximum insertional torque (R2≤59.6%, p<.03) provided better correlations to screw loosening compared with all the other bone quality parameters. CONCLUSIONS: Our findings indicate that bone quality in the vertebral body varied spatially depending on the orientation and the insertion location of the IFC screw. These alterations in local bone quality significantly affected the screw's ability to fixate to bone. These variations in bone quality may be assessed intraoperatively using screw insertional torque measurements. By understanding available bone purchase at the bone-implant interface, the appropriate implant design can be selected to maximize the fixation strength.

The effects of surface processing on in-vivo corrosion of Nitinol stents in a porcine model.

A major limitation with current assessments of corrosion in metallic medical devices is the lack of correlation between in-vitro and in-vivo corrosion performance. Therefore, the objective of this study was to elucidate the relationship between pitting corrosion measured by breakdown potentials (Eb) in ASTM F2129 testing and corrosion resistance in-vivo. Four groups of Nitinol stents were manufactured using different processing methods to create unique surface properties. The stents were implanted into iliac arteries of minipigs for six months and explanted for corrosion analysis. Scanning electron microscopy and energy dispersive X-ray spectrometry analyses indicated that stents with a thick complex thermal oxide (420nm) and high corrosion resistance in-vitro (Eb=975±94mV) were free from detectable corrosion in-vivo and exhibited no changes in Ni/Ti ratio when compared to non-implanted controls. This result was also found in mechanically polished stents with a thin native oxide (4nm; Eb=767±226mV). In contrast, stents with a moderately thick thermal oxide (130nm) and low corrosion resistance in-vitro (Eb=111±63mV) possessed corrosion with associated surface microcracks in-vivo. In addition, Ni/Ti ratios in corroded regions were significantly lower compared to non-corroded adjacent areas on explanted stents. When stents were minimally processed (i.e. retained native tube oxide from the drawing process), a thick thermal oxide was present (399nm) with low in-vitro corrosion resistance (Eb=68±29mV) resulting in extensive in-vivo pitting. These findings demonstrate that functional corrosion testing combined with a detailed understanding of the surface characteristics of a Nitinol medical device can provide insight into in-vivo corrosion resistance. STATEMENT OF SIGNIFICANCE: Nitinol is a commonly used material in the medical device industry. However, correlations between surface processing of nitinol and in-vivo corrosion has yet to be established. Elucidating the link between in-vivo corrosion and pre-clinical characterization can aid in improved prediction of clinical safety and performance of nitinol devices. We addressed this knowledge gap by fabricating nitinol stents to possess distinct surface properties and evaluating their corrosion susceptibility both in-vitro and after six months of in-vivo exposure. Relationships between stent processing, surface characterization, corrosion bench testing, and outcomes from explanted devices are discussed. These findings highlight the importance of surface characterization in nitinol devices and provide in-vitro pitting corrosion levels that can induce in-vivo corrosion in nitinol stents.

Integrated Fixation Cage Loosening Under Fatigue Loading.

BACKGROUND: Screw loosening is a well-known adverse event in traditional spinal fusion instrumentation. This phenomenon may hinder segmental stability of the spine leading to bony non-union. In recent years numerous lumbar integrated fixation cages (IFC) have been introduced that offer a low profile alternative to a standard cage with an anterior plate (AP+C). The fixation approach for IFCs is different than a traditional anterior approach; therefore, it is unclear whether IFCs may loosen from the surrounding bone over time. The purpose of this study was to quantify screw loosening of IFC devices compared to AP+C implants under fatigue loading using micro-CT and image processing techniques. METHODS: L2-3 and L4-5 functional spinal units (FSUs) were obtained from nine human lumbar spines. These FSUs were then reconstructed with either AP+C or IFC implants designed to attach to vertebral bodies using four screws (two top and two bottom for AP+C; two medial and two lateral for IFC). The reconstructed specimens were fatigued in flexion-extension load of ±3 Nm at 1Hz for first 5,000 cycles and it was increased to ±5 Nm until 20,000 cycles. After removing screws to prevent image artifact, micro-CT scans were performed on all FSUs post-fatigue. These images were post-processed to calculate three-dimensional volumes around screw holes created due to damage at the screw-implant interface. RESULTS: IFC screws had significantly greater (p=0.008) screw hole volumes compared to AP+C screws after fatigue testing. This increased screw hole volume for IFC devices was mainly due to loosening in medial screws. Medial screws had significantly greater (p<0.003) screw hole volumes compared to lateral IFC screws and all AP+C screws. There was no difference (p>0.888) between the screw hole volumes of lateral IFC, top AP+C, and bottom AP+C screws. CONCLUSIONS: This study elucidated screw-loosening mechanisms in integrated fixation cages under simulated physiological loading. In particular, spatial differences in fixation was observed for IFC screws across the vertebra where medial screws loosened at a greater frequency compared to lateral screws post-fatigue. This novel technique may also be used to quantitatively investigate screw fixation post-fatigue testing in a variety of spinal devices.

Relationships among ultrasonic and mechanical properties of cancellous bone in human calcaneus in vitro.

Clinical bone sonometers applied at the calcaneus measure broadband ultrasound attenuation and speed of sound. However, the relation of ultrasound measurements to bone strength is not well-characterized. Addressing this issue, we assessed the extent to which ultrasonic measurements convey in vitro mechanical properties in 25 human calcaneal cancellous bone specimens (approximately 2×4×2cm). Normalized broadband ultrasound attenuation, speed of sound, and broadband ultrasound backscatter were measured with 500kHz transducers. To assess mechanical properties, non-linear finite element analysis, based on micro-computed tomography images (34-micron cubic voxel), was used to estimate apparent elastic modulus, overall specimen stiffness, and apparent yield stress, with models typically having approximately 25-30 million elements. We found that ultrasound parameters were correlated with mechanical properties with R=0.70-0.82 (p<0.001). Multiple regression analysis indicated that ultrasound measurements provide additional information regarding mechanical properties beyond that provided by bone quantity alone (p≤0.05). Adding ultrasound variables to linear regression models based on bone quantity improved adjusted squared correlation coefficients from 0.65 to 0.77 (stiffness), 0.76 to 0.81 (apparent modulus), and 0.67 to 0.73 (yield stress). These results indicate that ultrasound can provide complementary (to bone quantity) information regarding mechanical behavior of cancellous bone.

Development of a Flow Evolution Network Model for the Stress-Strain Behavior of Poly(L-lactide).

Computational modeling is critical to medical device development and has grown in its utility for predicting device performance. Additionally, there is an increasing trend to use absorbable polymers for the manufacturing of medical devices. However, computational modeling of absorbable devices is hampered by a lack of appropriate constitutive models that capture their viscoelasticity and postyield behavior. The objective of this study was to develop a constitutive model that incorporated viscoplasticity for a common medical absorbable polymer. Microtensile bars of poly(L-lactide) (PLLA) were studied experimentally to evaluate their monotonic, cyclic, unloading, and relaxation behavior as well as rate dependencies under physiological conditions. The data were then fit to a viscoplastic flow evolution network (FEN) constitutive model. PLLA exhibited rate-dependent stress-strain behavior with significant postyield softening and stress relaxation. The FEN model was able to capture these relevant mechanical behaviors well with high accuracy. In addition, the suitability of the FEN model for predicting the stress-strain behavior of PLLA medical devices was investigated using finite element (FE) simulations of nonstandard geometries. The nonstandard geometries chosen were representative of generic PLLA cardiovascular stent subunits. These finite element simulations demonstrated that modeling PLLA using the FEN constitutive relationship accurately reproduced the specimen's force-displacement curve, and therefore, is a suitable relationship to use when simulating stress distribution in PLLA medical devices. This study demonstrates the utility of an advanced constitutive model that incorporates viscoplasticity for simulating PLLA mechanical behavior.

Retrieval and clinical analysis of distraction-based dual growing rod constructs for early-onset scoliosis.

BACKGROUND CONTEXT: Growing rod constructs are an important contribution for treating patients with early-onset scoliosis. These devices experience high failure rates, including rod fractures. PURPOSE: The objective of this study was to identify the failure mechanism of retrieved growing rods, and to identify differences between patients with failed and intact constructs. STUDY DESIGN/SETTING: Growing rod patients who had implant removal and were previously enrolled in a multicenter registry were eligible for this study. PATIENT SAMPLE: Forty dual-rod constructs were retrieved from 36 patients across four centers, and 34 of those constructs met the inclusion criteria. Eighteen constructs failed due to rod fracture. Sixteen intact constructs were removed due to final fusion (n=7), implant exchange (n=5), infection (n=2), or implant prominence (n=2). OUTCOME MEASURES: Analyses of clinical registry data, radiographs, and retrievals were the outcome measures. METHODS: Retrievals were analyzed with microscopic imaging (optical and scanning electron microscopy) for areas of mechanical failure, damage, and corrosion. Failure analyses were conducted on the fracture surfaces to identify failure mechanism(s). Statistical analyses were performed to determine significant differences between the failed and intact groups. RESULTS: The failed rods fractured due to bending fatigue under flexion motion. Construct configuration and loading dictate high bending stresses at three distinct locations along the construct: (1) mid-construct, (2) adjacent to the tandem connector, or (3) adjacent to the distal anchor foundation. In addition, high torques used to insert set screws may create an initiation point for fatigue. Syndromic scoliosis, prior rod fractures, increase in patient weight, and rigid constructs consisting of tandem connectors and multiple crosslinks were associated with failure. CONCLUSION: This is the first study to examine retrieved, failed growing rod implants across multiple centers. Our analysis found that rod fractures are due to bending fatigue, and that stress concentrations play an important role in rod fractures. Recommendations are made on surgical techniques, such as the use of torque-limiting wrenches or not exceeding the prescribed torques. Additional recommendations include frequent rod replacement in select patients during scheduled surgeries.

Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration.

Cervical intervertebral body fusion devices (IBFDs) are utilized to provide stability while fusion occurs in patients with cervical pathology. For a manufacturer to market a new cervical IBFD in the United States, substantial equivalence to a cervical IBFD previously cleared by FDA must be established through the 510(k) regulatory pathway. Mechanical performance data are typically provided as part of the 510(k) process for IBFDs. We reviewed all Traditional 510(k) submissions for cervical IBFDs deemed substantially equivalent and cleared for marketing from 2007 through 2014. To reduce sources of variability in test methods and results, analysis was restricted to cervical IBFD designs without integrated fixation, coatings, or expandable features. Mechanical testing reports were analyzed and results were aggregated for seven commonly performed tests (static and dynamic axial compression, compression-shear, and torsion testing per ASTM F2077, and subsidence testing per ASTM F2267), and percentile distributions of performance measurements were calculated. Eighty-three (83) submissions met the criteria for inclusion in this analysis. The median device yield strength was 10,117N for static axial compression, 3680N for static compression-shear, and 8.6Nm for static torsion. Median runout load was 2600N for dynamic axial compression, 1400N for dynamic compression-shear, and ±1.5Nm for dynamic torsion. In subsidence testing, median block stiffness (Kp) was 424N/mm. The mechanical performance data presented here will aid in the development of future cervical IBFDs by providing a means for comparison for design verification purposes.

Biomechanical evaluation of an integrated fixation cage during fatigue loading: a human cadaver study.

OBJECTIVE Lumbar cages with integrated fixation screws offer a low-profile alternative to a standard cage with anterior supplemental fixation. However, the mechanical stability of integrated fixation cages (IFCs) compared with a cage with anterior plate fixation under fatigue loading has not been investigated. The purpose of this study was to compare the biomechanical stability of a screw-based IFC with a standard cage coupled with that of an anterior plate under fatigue loading. METHODS Eighteen functional spinal units were implanted with either a 4-screw IFC or an anterior plate and cage (AP+C) without integrated fixation. Flexibility testing was conducted in flexion-extension (FE), lateral bending (LB), and axial rotation (AR) on intact spines, immediately after device implantation, and post-fatigue up to 20,000 cycles of FE loading. Stability parameters such as range of motion (ROM) and lax zone (LZ) for each loading mode were compared between the 2 constructs at multiple stages of testing. In addition, construct loosening was quantified by subtracting post-instrumentation ROM from post-fatigue ROM. RESULTS IFC and AP+C configurations exhibited similar stability (ROM and LZ) at every stage of testing in FE (p ≥ 0.33) and LB (p ≥ 0.23) motions. In AR, however, IFCs had decreased ROM compared with AP+C constructs at pre-fatigue (p = 0.07) and at all post-fatigue time points (p ≤ 0.05). LZ followed a trend similar to that of ROM in AR. ROM increased toward intact motion during fatigue cycling for AP+C and IFC implants. IFC specimens remained significantly (p < 0.01) more rigid than specimens in the intact condition during fatigue for each loading mode, whereas AP+C construct motion did not differ significantly (p ≥ 0.37) in FE and LB and was significantly greater (p < 0.01) in AR motion compared with intact specimens after fatigue. Weak to moderate correlations (R2 ≤ 56%) were observed between T-scores and construct loosening, with lower T-scores leading to decreased stability after fatigue testing. CONCLUSIONS These data indicate that a 4-screw IFC design provides fixation similar to that provided by an AP+C construct in FE and LB during fatigue testing and better stability in AR motion.

Current practices in corrosion, surface characterization, and nickel leach testing of cardiovascular metallic implants.

In an effort to better understand current test practices and improve nonclinical testing of cardiovascular metallic implants, the Food and Drug Administration (FDA) held a public workshop on Cardiovascular Metallic Implants: corrosion, surface characterization, and nickel leaching. The following topics were discussed: (1) methods used for corrosion assessments, surface characterization techniques, and nickel leach testing of metallic cardiovascular implant devices, (2) the limitations of each of these in vitro tests in predicting in vivo performance, (3) the need, utility, and circumstances when each test should be considered, and (4) the potential testing paradigms, including acceptance criteria for each test. In addition to the above topics, best practices for these various tests were discussed, and knowledge gaps were identified. Prior to the workshop, discussants had the option to provide feedback and information on issues relating to each of the topics via a voluntary preworkshop assignment. During the workshop, the pooled responses were presented and a panel of experts discussed the results. This article summarizes the proceedings of this workshop and background information provided by workshop participants. Published 2016. This article is a U.S. Government work and is in the public domain in the USA. J Biomed Mater Res Part B: Appl Biomater, 105B: 1330-1341, 2017.

The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices.

The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitations in the ideation stage. To supplement bench data in regulatory submissions, manufactures can evaluate the effects of anatomical characteristics and expected in vivo loading environment on device performance. Manufacturers might also harness CM&S to aid root-cause analyses that are necessary when failures occur postmarket, when the device is exposed to broad clinical use. Once identified, CM&S tools can then be used for redesign to address the failure mode and re-establish the performance profile with the appropriate models. The Center for Devices and Radiological Health (CDRH) wants to advance the use of CM&S for medical devices and supports the development of virtual physiological patients, clinical trial simulations, and personalized medicine. Thus, the purpose of this paper is to describe specific examples of how CM&S is currently used to support regulatory submissions at different phases of the TPLC and to present some of the stakeholder-led initiatives for advancing CM&S for regulatory decision-making.

Comparisons of Anterior Plate Screw Pullout Strength Between Polyurethane Foams and Thoracolumbar Cadaveric Vertebrae.

Synthetic polyurethane foams are frequently used in biomechanical testing of spinal medical devices. However, it is unclear what types of foam are most representative of human vertebral trabecular bone behavior, particularly for testing the bone-implant interface. Therefore, a study was conducted to compare polyurethane foam microstructure and screw pullout properties to human vertebrae. Cadaveric thoracolumbar vertebrae underwent microcomputed tomography to assess trabecular bone microstructure. Spine plate screws were implanted into the vertebral body and pullout testing was performed. The same procedure was followed for eight different densities (grades 5-30) of commercially available closed cell (CCF) and open cell foams (OCF). The results indicated that foam microstructural parameters such as volume fraction, strut thickness, strut spacing, and material density rarely matched that of trabecular bone. However, certain foams provided mechanical properties that were comparable to the cadavers tested. Pullout force and work to pullout for screws implanted into CCF grade 5 were similar to osteoporotic female cadavers. In addition, screw pullout forces and work to pullout in CCF grade 8, grade 10, and OCF grade 30 were similar to osteopenic male cadavers. All other OCF and CCF foams possessed pullout properties that were either significantly lower or higher than the cadavers tested. This study elucidated the types and densities of polyurethane foams that can represent screw pullout strength in human vertebral bone. Synthetic bone surrogates used for biomechanical testing should be selected based on bone quantity and quality of patients who may undergo device implantation.

Effects of fatigue on the chemical and mechanical degradation of model stent sub-units.

Understanding the fatigue and durability performance of implantable cardiovascular stents is critical for assessing their performance. When the stent is manufactured from an absorbable material, however, this durability assessment is complicated by the transient nature of the device. Methodologies for evaluating the fatigue performance of absorbable stents while accurately simulating the degradation are limited and little is known about the interaction between fatigue and degradation. In this study, we investigated the fatigue behavior and effect of fatigue on the degradation rate for a model absorbable cardiovascular stent. Custom v-shaped stent sub-units manufactured from poly(L-lactide), i.e., PLLA, were subjected to a simultaneous fatigue and degradation study with cycle counts representative of one year of expected in vivo use. Fatigue loading was carried out such that the polymer degraded at a rate that was aligned with a modest degree of fatigue acceleration. Control, un-loaded specimens were also degraded under static immersion conditions representative of simulated degradation without fatigue. The study identified that fatigue loading during degradation significantly increased specimen stiffness and lowered the force at break. Fatigue loading also significantly increased the degree of molecular weight decline highlighting an interaction between mechanical loading and chemical degradation. This study demonstrates that fatigue loading during degradation can affect both the mechanical properties and the chemical degradation rate. The results are important for defining appropriate in vitro degradation conditions for absorbable stent preclinical evaluation.